A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00603473

Purpose

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Condition	Intervention	Phase
Epilepsies, Partial	Drug: gabapentin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Responder Rate, Percent change in seizure frequency, Pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	92
Study Start Date:	January 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
gabapentin: Experimental	Drug: gabapentin Orally administered gabapentin

Eligibility

Ages Eligible for Study:	3 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
Have not been able to achieve adequate seizure control with antiepileptic drugs

Exclusion Criteria:

Seizures related to drugs or acute medical illness
History of any serious medical or psychiatric disorder
Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603473

Show 26 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A9451162
Study First Received:	January 16, 2008
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00603473 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Epilepsies, Partial
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Brain Diseases
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses

Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Epilepsy
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2010